Prorox (Seipel Group Pty Ltd)
Product Name
Prorox
Sponsor
ARTG
353308
Date of review outcome
Date of publication
Jun-23
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, follow the recommended actions below.
What action should consumers take?
Seek advice from a suitably qualified health practitioner if you are or have been using this medicine to treat symptoms of undiagnosed overactive bladder which may include urinary frequency, urgency and frequent night-time urination.
Consider whether this medicine is right for you based on this medicine potentially not working as expected in relation to lower urinary tract symptoms, nocturia, poor bladder control, overactive bladder and as an antioxidant.
Consider whether this medicine is right for you based on this medicine potentially not working as expected in relation to lower urinary tract symptoms, nocturia, poor bladder control, overactive bladder and as an antioxidant.
Review scope
Targeted
Information reviewed
ARTG Record, Website
Issues related to safety
The website for this medicine stated or implied that it could relieve symptoms of overactive bladder, which is a condition that requires diagnosis, treatment and/or supervision by a suitably qualified health practitioner. References to overactive bladder without the qualifier 'medically diagnosed' are not permitted for medicines that are available for self-selection. This claim has the potential to lead consumers to delay access to timely medical advice or treatment resulting in adverse outcomes. However, the website for this medicine also advised consumers to see a health professional if symptoms persist. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The website for this medicine contained claims specified in 'What action should consumers take?' above. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine's website. The sponsor updated the website to correct the issues.